[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"posterior-urethral-valve\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:posterior-urethral-valve":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,90,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100410565","early-phase-1-concomitant-renal-and-urinary-bladder-allograft-transplantation-100410565",false,"NCT04626167","Concomitant Renal and Urinary Bladder Allograft Transplantation","Inclusion Criteria:\n\n* Male or female patients between 1 yr. and 60 years of age.\n* Subject is willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children 6-17 years of age as appropriate or warranted.\n* Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder.\n* Medical need for a bladder transplant, as defined by the presence of exhibiting \"hostile bladders\" defined as end filling pressure or detrusor leak point pressure (DLPP) of or greater than 40 cm H20 or at below estimated bladder capacity for age, or detrusor overactivity with detrusor sphincter dyssynergia, or new onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months\n* If a concomitant kidney transplant is being considered, additionally, estimated GFR less than or equal to 20 mL\u002Fmin or dialysis. If GFR 20-25 mL\u002Fmin would also qualify if expected progression is rapid (\\>10 mL\u002Fmin\u002Fyear)\n* Vetting and approval by the Mayo Clinic multidisciplinary transplant team (MDC) for renal transplantation.\n* Ability of subject and\u002For care provider to be successfully trained in clean intermittent catheterization and bladder cycling. Or current use of CIC.\n* Utilization of maximally-tolerated dose and regimen of medical therapy (e.g. anticholinergics) or failure to tolerate\u002Fcontraindications to such agents.\n* Psychosocial clearance: Demonstrated commitment to psychological evaluation perioperatively, in which the psychologist must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study.\n* Agree to avoid pregnancy for 1 year after surgery through abstinence or approved contraception as noted in Appendix A (female subjects only)\n* If patient has a history of malignancy (with the exception of localized non-melanoma skin cancer) the patient must be at least 5 years from termination of treatment without evidence of recurrent disease.\n\nExclusion Criteria:\n\n* They are pregnant or breastfeeding, or planning a pregnancy during the course of the study, or who are of child bearing potential and not willing to continue using an effective method of birth control (i.e. with a low failure rate of less than 1 percent per year including injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner), or\n* Any contraindication to general anesthesia or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative recovery due to severe cardiovascular, pulmonary, neurological, metabolic, or rheumatologic disease (requires special consultation)\n* Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin\n* Subjects with a current positive (\\>=5 mm induration for high-risk subjects; otherwise \\>=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.\n* Known history of hypersensitivity to aminoglycosides or fluoroquinolones\n* Use of any investigational product within 3 months\n* Prior participation in the study\n* Currently smoking\n* Current incarceration for any reason\n* Unwillingness, inability, or unlikely compliance of individual and\u002For primary caregiver with study related schedules procedures, management, or follow -up in the opinion of the PI and\u002For co-investigators\n* Any circumstance in which the investigator deems participation in the study is not in the subject's best interest\n* Subjects with an ALT or AST value \\>3 times the upper limit of normal\n* Subjects with acute or chronic abdominal skin infections and\u002For acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease\n* Subjects with uncontrolled diabetes defined as HgA1c\\>10, unstable cardiac and\u002For pulmonary disorders, or bleeding disorders\n* Active malignant neoplasm (with the exception of localized non-melanoma skin cancer) that is untreated, unresponsive to available treatment, or too recently treated to determine relapse risk.\n* Surgical procedure for transplantation cannot be successfully performed for anatomical reasons\n* Life expectancy with successful transplantation is estimated to be \\\u003C5 years for any reason.\n* There is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the procedure or the interpretation of results or render the subject at high risk for treatment complications, or\n* Serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits\u002Fcare after transplant, or\n* Taking medications on specified hourly intervals that may be affected by changes to renal clearance, or\n* Hypertension stage II \\> 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or\n* Presence of severe coagulopathy, (hyper or hypo)\n* Patient is not up to date on current CDC recommended vaccines","ALL","1 Year","60 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.",[26,27,28,29,30,31,32,33,34],"Chronic Kidney Diseases","Bladder Dysfunction","Bladder Absence","Posterior Urethral Valve","Neurogenic Bladder","Bladder Exstrophy","Bladder Outlet Obstruction","Failure, Kidney","Transplant",[36,37,38,39,40],"Urinary Bladder Transplant","Bladder Transplant","Bladder Augment","Neobladder","Ileocystoplasty","RECRUITING","2026-04-20",{"date":44,"type":45},"2026-04-23","ACTUAL",{"date":47,"type":45},"2021-06-01",{"date":49,"type":20},"2026-08",{"name":51,"class":52},"Mayo Clinic","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":89},"100549884","study-of-the-quality-of-life-in-school-aged-children-with-posterior-urethral-valves-100549884","NCT06439862","Study of the Quality of Life in School Aged-children With Posterior Urethral Valves","Quality of Life in School Aged-children With Posterior Urethral Valves","QUALIVUP","Inclusion Criteria:\n\n* Male patients and their parents\u002Frelatives\n* Aged 6 to 17 years old\n* Treated for PUV in their first year of life between 2006 and 2018\n* Managed in the Femme-Mère-Enfant Hospital in Lyon\n\nExclusion Criteria:\n\n* Children with pre-existing severe cognitive and physical disability (physician's rating) from other condition\n* Children enable to complete QoL questionnaire due to mental or communication impairment","MALE","6 Years","17 Years",{"count":66,"type":20},300,"OBSERVATIONAL","Posterior urethral valves (PUV) are the most common congenital obstructive lesion of the urethra, affecting from 1 per 3000 to 1 per 8000 live births. Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions.\n\nRenal insufficiency is the most feared long-term complication. Up to 50 % of the patients will develop chronic kidney disease (CKD), and up to 20 % will develop end-stage renal disease (ESRD) and ultimately will require kidney transplantation. PUV is the first urological cause of ESRD. Progression towards CKD depends on febrile urinary tract infections (UTIs), severity of a vesicoureteral reflux and bladder dysfunction.\n\nBladder dysfunction is due to an overactive and small poorly compliant bladder during infancy. Detrusor overactivity usually decreases in childhood and bladder capacity increases. The most common symptom of this bladder dysfunction is urinary incontinence. 60 % of children are continent at the age of 5 years old and 90 % at 10 years old. In case of persistent bladder dysfunction, medical treatment (anticholinergics, alpha-blockers) may be introduced, or even intermittent catheterizations.\n\nCurrent scientific literature has very few studies on quality of life (QoL) in patients with PUV, mostly in adult patients and very small cohorts. Men treated for PUV in childhood had a good quality of life compared to the normative population, except for sleeping, eating and sexual activity. It seemed that the more severe the urological and nephrological functions were, the lower the QoL was. Children were only asked about intermittent urinary catheterization, and family point of view has never been collected. However, QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling, or after diagnosis in an infant with PUV.\n\nHence, the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life, as measured by the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).",[70,29,71,72,73,27,74],"Quality of Life","Renal Insufficiency","Chronic Renal Disease","End Stage Renal Disease","Urinary Incontinence",[76,77,78,79,80],"Quality of life","Posterior Urethral Valves","Children","Adolescents","Family","2025-05-05",{"date":83,"type":45},"2025-05-07",{"date":85,"type":45},"2024-08-20",{"date":49,"type":20},{"name":88,"class":52},"Hospices Civils de Lyon",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":62,"minAge":4,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100582742","outcomes-of-posterior-urethral-valve-fulguration-100582742","NCT06867263","Outcomes of Posterior Urethral Valve Fulguration","Long-term Evaluation of Patients With Fulguration of Posterior Urethral Valve: A Retrospective Cohort Study","Inclusion Criteria:\n\n* Patients with fulguration of PUV since 1 year or more\n\nExclusion Criteria:\n\n* Patients with neurogenic bladder or meningocele or spina bifida .\n\nPatients with renal parenchymal disease and inflammation not related to posterior urethral valve .\n\nDiabetic patients .\n\nParental refusal .",{"count":98,"type":20},35,"To evaluate the long-term outcome after fulguration of the posterior urethral valve.",[29],"NOT_YET_RECRUITING","2025-03-07",{"date":104,"type":45},"2025-03-10",{"date":106,"type":20},"2025-05-01",{"date":108,"type":20},"2027-07-01",{"name":110,"class":52},"Assiut University",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":62,"minAge":4,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":89},"100572726","phase-3-efficacy-and-safety-of-tamsulosin-for-children-with-posterior-urethral-valve-100572726","NCT06737016","Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.","Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Children with a diagnosis of PUV.\n\nExclusion Criteria:\n\n1. Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome)\n2. Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.\n3. Patients who had primary treatment of PUV ablation at other hospitals.\n4. Contraindications to α blocker treatment.\n5. Patients who refuse to participate in the study","12 Years",{"count":120,"type":20},50,[122],"PHASE3","To determine whether there is a role for Tamsulosin, A Selective Alpha-1 Adrenergic Blocker, as therapy in children with Posterior Urethral Valve post valve ablation , and whether there are side effects involved.",[29],[29],"2024-12-19",{"date":128,"type":45},"2024-12-20",{"date":130,"type":45},"2024-11-01",{"date":132,"type":20},"2026-11",{"name":134,"class":52},"Mansoura University"]